Watching the IUD go in: can a camera make contraception safer?
NCT ID NCT05702281
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing a new inserter called ReLARC for placing a frameless copper intrauterine device (GyneFix). The inserter works with a hysteroscope, a thin camera that lets the doctor see inside the uterus during placement. The study enrolls 120 healthy women aged 18 to 48 who want long-term contraception. Doctors will check whether the device ends up in the right position and how smoothly the insertion goes, then follow participants for three years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a frameless copper intrauterine device placed with a camera-guided inserter
- What this could lead to
- If it works, women could have a more reliable and safer option for long-term, hormone-free contraception. The camera-guided approach may make insertion more predictable for doctors.
- What could go wrong
- This is an early study with 120 women, so it cannot prove the approach is better than standard insertion. Insertion can cause cramping, bleeding, or, rarely, perforation, and the device may shift or be expelled over time.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 48 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Generally healthy women, 18 - 48 years of age and not having a contraindication for hysteroscopy * Be willing to come back for the follow-ups * Be willing to refrain from having intercourse the first two weeks and using tampons and menstrual cups in the first 2 months, following insertion * Sign a written informed consent * Fundus thickness should be 11mm or more Exclusion Criteria: * T and Y shaped uterus * U1, dysmorphic uterus (abnormal myometrium may result in bad device fixation) * Complete septate U2b uterus * Bicorporal U3-U6 uterus * Injectables contraceptive use in the last 6 months * The presence of infection of the uterus, clinical cervicitis or vaginitis (infection should be ruled out) * Intrauterine fibroids (intra-mural, intracavitary or submucosal) * Cancer or other disease of the uterus * Malignancy, or treatment for malignancy. Melanoma or any gynaecological cancer at any time excludes the subject * Blood clotting disorders * Intrauterine polyps * Subjects receiving corticosteroid therapy or immunosuppressive drugs * Morbus Wilson * AIDS * Pregnancy
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital
RECRUITINGGhent, 9000, Belgium
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